Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children
2 other identifiers
interventional
77
1 country
1
Brief Summary
To determine the efficacy of tacrolimus in the management of NS(nephrotic syndrome) , the investigators designed this prospective study. The investigators will enroll 100 children with NS(frequent relapse steroid dependent NS, steroid resistance NS) who will be treated with tacrolimus (0.1-0.2 mg/kg/day in two divided doses over 12 h adjusted to a trough level between 5 and 10 ng/ml) for 12 months in combination with low-dose steroids. Other therapies will be included angiotensin-converting enzyme inhibitors, antihypertensive drugs, multivitamins and lipid-lowering agents. Follow-up is every second week for the first 4 weeks, then monthly. After initiation of tacrolimus therapy, blood was drawn each visit to determine tacrolimus trough levels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2010
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 12, 2010
CompletedFirst Posted
Study publicly available on registry
July 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
February 7, 2019
CompletedFebruary 7, 2019
September 1, 2018
3.2 years
July 12, 2010
November 12, 2016
September 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Remission Rate
Complete remission at 12 months Per KDIGO clinical practice guideline for glomerulonephritis (2012): Complete remission (CR), urine protein creatinine ratio below 200mg/g (20mg/mmol) or 1+ of protein on urine dipstick for 3 consecutative days
12-month treatment period
Secondary Outcomes (1)
Duration of Remission
12-month treatment period
Study Arms (1)
Tacrolimus
EXPERIMENTALTacrobell
Interventions
dosage : 0.1-0.2 mg/kg/day divided two target trough level : 5 - 10 ng/mL Total duration (tacrolimus) : 1 year
Eligibility Criteria
You may qualify if:
- Frequent relapse nephrotic syndrome
- steroid resistance nephrotic syndrome
You may not qualify if:
- secondary nephrotic syndrome
- estimated glomerular filtration rate \< 60 mL/min/1.73m2
- with active hepatitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Chong Kun Dang Pharmaceuticalcollaborator
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Hee Gyung Kang
- Organization
- Seoul National University Children's Hospital
Study Officials
- STUDY CHAIR
ILSOO Ha, MD, PhD
Seoul National Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study chair
Study Record Dates
First Submitted
July 12, 2010
First Posted
July 14, 2010
Study Start
July 1, 2010
Primary Completion
September 1, 2013
Study Completion
October 1, 2013
Last Updated
February 7, 2019
Results First Posted
February 7, 2019
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share